FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CURETTE
DI: 04953170062230
·
Model: CC-4CR-1
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CURETTE
- Primary DI
- 04953170062230
- Version / Model
- CC-4CR-1
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 8
- Public Version Date
- 2022-08-11
- Public Version Status
- Update
- Public Device Record Key
- d9e03ec5-a8cd-448a-820b-e37b1a94ef6e
- Distribution End Date
- 2022-08-10
Device Description
CC-4CR-1 ROT DOUBLE JOINT CYTO CURETTE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
| BST | Curette, biopsy, bronchoscope (non-rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31248 | Bronchoscopic biopsy curette, flexible, reusable | A flexible device intended to be used through a flexible bronchoscope to obtain specimens of the bronchi for histological/pathological diagnosis during bronchoscopy. It is a type of biopsy forceps whose flexible insertion portion is made of a metal coil or a plastic tube, but where at the distal end terminates in a sharply-pointed scoop/receptacle for securing the biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170062237 | GS1 | 1 | Not in Commercial Distribution | 2022-08-10 | |
| Primary | 04953170062230 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]